Non small cell lung cancer, stage IV Patients are eligible if when they are planned to start immunotherapy according to standard routines and are not in need of radiotherapy
Conditions
Interventions
Trade Name: Pembrolizumab (KEytruda)
Product Name: Keytruda
Pharmaceutical Form: Injection/infusion
Trade Name: Atezolizumab (Tecentriq)
Pharmaceutical Form: Injection/infusion
Trade Name: Nivolumab
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Written informed consent 3. Advanced NSCLC with clinical indication of starting systemic treatment with immunotherapy alone or in combination with chemotherapy (first or later lines) 4. Available core or excisional biopsy of a tumour lesion 5. Measurable disease according to RECIST criteria (RECIST 1.1) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Life expectancy > 3 months 8. At least 1 tumour lesion suitable for radiotherapy treatment 9. Adequate organ function based on clinical examination and lab values Hb>9 g/dL Neutrophils >1500 pr mm3 Estimated creatinin clearance >40 mL/min AST and ALT =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Disease suitable for curative salvage surgery 2. Indication for radiotherapy other than stereotactic radiosurgery of brain metastases 3. Treatment with any investigational medicinal product (IMP) that may interfere with the study treatment, within 2 weeks prior to first administration of study drug. 4. Expected use of anti-inflammatory medications as defined in 5.7.1 during the treatment period 5. Significant cardiac, pulmonary or other medical illness that would limit activity or survival 6. Previous treatment with PD1/PDL-1 inhibitor 7. Radiotherapy given within the last 4 weeks prior to inclusion 8. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan 9. Pregnancy or lactation 10. Women who are not postmenopausal (postmenopausal defined as = 12 months of non-drug-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 2 weeks prior to initiation of study drug 11. Patients with EGFR-mutation or ALK-translocation not previously treated with tyrosine kinase inhibitor 12. Known hypersensitivity to the immunotherapy regimen planned for the patient the investigational product 13. Patients who test positive for hepatitis B, C or HIV. 14. Known larger active brain metastases that cannot be treated with stereotactic radiotherapy. Patients with stable/previously treated brain metastases can be included. Patients with several smaller brain metastases may be included if the larger metastases are treated with stereotactic radiotherapy 15. Live vaccine administered last 30 days, active infection requiring IV antibiotics, active viral hepatitis or HIV 16. Previous allogenic or organ transplant 17. Diagnosis of immunodeficiency or medical condition requiring high doses (>20 mg prednisolone daily) of systemic steroids or other forms of immunosuppressive therapy 18. Any reason why, in the opinion of the investigator, the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the trial is to study the acute and subacute toxicity of adding extensive radiotherapy to immunotherapy in the treatment of non small cell lung cancer with stage IV disease;Secondary Objective: The secondary objectives are to study the effect and quality of life of the treatment in question. Specifically, secondary objectives are to evaluate: - progression free survival and overall survival - response rate, duration of respons - Time to NeXT treatment - Health related quality of life - therapy response in non-irradiated lesions, if any Exploratory objectives: Investigate - biomarkers of treatment response - immune response - imaging to predict therapy response - ctDNA as a tool to monitoring treatment effect;Primary end point(s): Primary: Acute (<3 months) and subacute (3-6 months) toxicity ;Timepoint(s) of evaluation of this end point: 3-6 monts | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PFS OS ORR DoR TNT HR-QoL: EORTC QLQ-C30 and QLQ-LC29;Timepoint(s) of evaluation of this end point: 3, 6 and 12, 18 and 24 months | — |
Countries
Norway
Contacts
Public ContactNational coordinator and PI
Oslo University Hospital
Outcome results
None listed